1. Field of the Invention
This invention relates to amine functional polyamides. Amine functional polyamides comprise amine and ammonium groups along the polymer chain. This invention further relates to the use of amine functional polyamides as pharmaceutical agents and in pharmaceutical compositions.
Mucositis is defined as inflammation and/or ulceration of a mucous membrane in the digestive tract. Mucositis can occur in the stomach, intestines and mouth. The disorder is characterized by breakdown of mucosa, which results in redness, swelling and/or the formation of ulcerative lesions.
Oral mucositis is a common dose-limiting toxicity of drug and radiation therapy for cancer; it occurs to some degree in more than one third of all patients receiving anti-neoplastic drug therapy. In granulocytopenic patients, the ulcerations that accompany mucositis are frequent portals of entry for indigenous oral bacteria leading to sepsis or bacteremia. There are about one million occurrences of oral mucositis annually in the United States. Mucositis also includes mucositis that develops spontaneously in a healthy patient not receiving ant-cancer therapy, as in the case of a canker sore or mouth ulcer. Improved therapies to treat mucositis are needed.
Surgical site infection (SSI) is an infection associated with a surgical procedure. Postoperative SSIs are a major source of illness, and less commonly death, in surgical patients (Nichols R L, 2001). The Guideline for Prevention of Surgical Site Infection (1999) sets forth recommendations for preventing SSIs.                Preoperative measures including proper preparation of the patient, antisepsis for surgical team, management of surgical personnel who exhibit signs of transmissible infectious illness, and antimicrobial prophylaxis.        Intra-operative measures including proper ventilation in the operating room, cleaning and disinfecting of surfaces in the surgical environment, microbiologic sampling, sterilization of surgical instruments, proper surgical attire and drapes, and proper asepsis and surgical technique.        Proper incision care post-operation, including sterile dressings and hand washing before and after dressing changes.        Continued surveillance of the surgical wound during the healing process.        
Despite these recommendations, SSIs develop in about 1 to 3 of every 100 patients who have surgery (CDC.gov, 2011). These infections can result in major complications that increase the costs and duration of post-operative hospital stays. Accordingly, novel approaches to mitigating SSIs are needed.
Cystic fibrosis (CF) is a genetic disease caused by a mutation in the cystic fibrosis transmembrane conductor regulator (CFTR) that results in abnormally thick and sticky mucus (Yu Q, et al., 2012). The thick, sticky mucus of a CF patient leads to compromised mucus clearance and lung infection. Chronic airway infections are one of the most common and debilitating manifestations of CF (Tümmler B and C Kiewitz, 1999). The stagnant mucus becomes a breeding ground for bacteria like Pseudomonas aeruginosa, which causes chronic airway infections (Moreau-Marquis S, G A O'Toole and B A Stanton, 2009). Despite the use of traditional antibacterial therapies in CF patients, most CF patients are afflicted with a chronic P. aeruginosa infection as teenagers and adults, leading to increased morbidity and mortality (Hoiby N, B Frederiksen B, T Pressler, 2005). In chronic P. aeruginosa infection, the P. aeruginosa forms biofilms, resulting in a greater tolerance to antibiotics and increasing difficulty in treatment (Yu Q, et al., 2012). Effective, novel treatments to assuage the effects of bacterial infection and biofilm formation in CF patients are needed.